4'-Deoxydoxorubicin (esorubicin) in non-Hodgkin's lymphomas and plasma cell tumors: First evidence of activity

From May, 1984 to December, 1985, 30 patients, 10 of them with non-Hodgkins lymphoma (NHL) and 20 with plasma-cell tumors (PCT) (19 multiple myeloma and 1 Waldenstrm's macroglobulinemia), entered two phase II studies with 4'-deoxydoxorubicin (esorubicin): 30 mg/m² i.v. every three weeks, with an increase to 35 mg/m² when bone marrow toxicity was absent after the first cycle, for at least two or three cycles prior to evaluation. The 25 evaluable patients received a median number of 3 courses of esorubicin (range 1-14). Among the 9 evaluable patients with NHL, 3 (33%) obtained CR and 2 (22%) PR for an overall 55% objective response rate. Two of the patients with CR had been previously treated with doxorubicin. Duration of response was short (9, 13, 14 weeks, respectively). No response was seen in 2 patients with Mycosis Fungoides. Among the 16 evaluable patients with PCT, 2 (12.5%) obtained a response, and 4 (25%) obtained improvement. None of these patients was previously treated with doxorubicin. Toxicity according to criteria proposed by WHO was acceptable in patients with NHL, whereas it was quite severe in patients with PCT, with two deaths from septicemia during the granulocytopenic periods. Congestive heart failure and change in the left ventricular ejection fraction were not evidenced in any patient, in particular not in the patient who has been treated with 14 cycles of esorubicin for a total dose of 300 mg/m². Although preliminary, our results have shown that esorubicin is capable of inducing a consistent proportion of objective responses in patients with NHL and PCT, even in those previously treated and resistant to doxorubicin.